
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
REVEAL LINQ™INSERTABLE CARDIAC MONITOR AND PATIENT ASSISTANT Patient Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. M955780A Rev A Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A_fc.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.Medtronic, Medtronic CareLink, MyCareLink, Reveal, Reveal LINQ, TUNA. 3 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A_contact.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm)Draft Medtronic Confidential LandPatMan_R1.1 M951593A001 Rev A How to contact MedtronicContact us by phoneOur experienced Patient Services gr oup is available to answer any questions or concerns you may have about your heart device. To speak directly with a Patient Services Specialist, call 1-800-551-5544. Our staff is available Monday through Friday from 8:00 AM to 5:00 PM (Central Time).Contact us onlineMedtronic is dedicated to providing you with the most up-to-date information available about your Medtronic heart device. Website information is available 24 hours a day. • Medtronic website: www.medtronic.com • Patient Services website: www.medtronic.com/rhythms 4 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A_contact.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm)Draft Medtronic Confidential LandPatMan_R1.1 M951593A001 Rev A If you would like to submit questions, suggestions, or requests to us online, you can use the online form provided at www.medtronic.com/contact-us.Contact us by mail or faxMedtronic Inc.Patient Services DepartmentMail Stop MVS 148200 Coral Sea Street NEMounds View, MN 55112Fax: (763) 367-5809 5 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780ATOC.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 ContentsChapter 1 Overview 7 Chapter 2 The insertion procedure, recovery, and follow-up 15 Chapter 3 Using your Patient Assistant 21 Chapter 4 Living life with your cardiac monitor 41 6 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780ATOC.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 English 7 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780A_ch1.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 1 Overview Your doctor should be your first source of information regarding your health. This manual addresses many of the questions you or your family may have about your cardiac monitor. If you have questions that are not covered in this manual or you want more in-depth information about your cardiac monitor, contact Medtronic (see page 3).Overview of the Medtronic Reveal LINQ systemYour doctor has recommended a Medtronic Reveal LINQ insertable cardiac monitor system. The Reveal LINQ system allows your heart’s electrical activity to be continuously monitored while you are away from your hospital or clinic. The system consists of your inserted cardiac monitor, the MyCareLink Patient Monitor that you generally keep by your bedside for automatic daily monitoring, and a handheld device called the Patient Assistant that you carry with you to easily record information about any heart-related events you experience. Table 1 provides an overview of the Reveal LINQ system. 8 English Chapter 1 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780A_ch1.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 Table 1. Overview of how the Reveal LINQ system is used to monitor and diagnose symptoms The Reveal LINQ cardiac monitor senses your heart rate continuously and, as programmed by your doctor, automatically stores heart-related events. If you experience a symptom such as dizziness, fainting, or palpitations , then during or very soon after experiencing a symptom, you press the button on the Patient Assistant and hold it over your cardiac monitor.Your heart doctor can monitor you by having the data from your cardiac monitor transmitted automatically to your clinic daily through your bedside MyCareLink Patient Monitor, if your doctor prescribed one. Overview 9 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780A_ch1.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 Next are additional details on the Reveal LINQ system components.Cardiac monitorThe Reveal LINQ cardiac monitor is inserted under your skin, generally in your left chest area. The cardiac monitor, shown above, is only about 1.8 in (4.5 cm) long, is less than 0.3 in (0.7 cm) wide, and it is very thin. It will likely be minimally noticeable under your skin. Your doctor can also monitor you through in-office clinic appointments. Your doctor will make sure your cardiac monitor is working correctly and review the data saved in the cardiac monitor. Table 1. Overview of how the Reveal LINQ system is used to monitor and diagnose symptoms (continued) 10 English Chapter 1 Refer to the “Patient manual Landscape/device” category in doc#163256 for Printing Instructions. M955780A Rev A M955780A_ch1.fm 7/29/13 7:07 amSize 6.0" x 4.625" (152 mm x 117 mm) Medtronic Confidential LandPatMan_R1.4 While you go about your daily activities, the cardiac monitor keeps track of your heart’s electrical activity. Recordings are store…
Text truncated - open the document above for the full version.
RADIO REGULATORY COMPLIANCE INFORMATION For devices supporting wireless telemetry FCC Compliance Information (FCC ID: LF5MEDSIMPLANT1) The following provision applies to the low frequency communications system in the device: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The following provision applies to the UHF communications system in the device: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. The following statement applies to the wireless receiver within the device: This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. *M955779A001* © Medtronic, Inc. 2013 M955779A001A 2013-07-12 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Europe/Middle East/Africa/ Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland +41218027000 Technical manuals: www.medtronic.com/manuals
WTD 13.4.9 FCC Compliance Opinion MDTR0228 Information about the Applicant Grantee (Company Name) Medtronic Inc. FCC Contact Person Address 710 Medtronic Parkway, LS250 City, State, Zip Fridley, MN 55432 Job Number MDTR0228 Model Reveal LinQ FCC ID LF5MEDSIMPLANT1 Agent Approval Type Original Equipment Class DCD Part 15, low power Tx below 1.705 MHz Rule Part Part 95 Overview Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 8/26/2013
September 9, 2013 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Request For Confidentiality FCC ID No.:LF5MEDSIMPLANT1 Ladies and Gentlemen: Medtronic, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Sections 0.457 and 0.459 of the Commission’s Rules, 47 C.F.R. following grant of the application. In support of this request, Medtronic submits the following: (1) identification of the specific information for which confidential treatment is sought: Schematics Parts List Block Diagrams Internal Photographs Operational Description The materials set forth in these exhibits, which are segregated from the non- confidential exhibits of the application, are those for which confidentiality is sought. (2) identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: The proceeding is that involving the application for and certification request for FCC ID No.: LF5MEDSIMPLANT1. (3) explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: This information is embodied in circuit diagrams, detailed explanations, parts lists, a block diagram and internal photographs of a sealed device designed for implantation in humans. The internal photographs are not released to the public. It is a Class 3 device regulated by the FDA and is available by prescription only. As such, this material is treated as highly confidential business information and Equipment Authorization Branch September 9, 2013 Page 2 information that could convey trade secrets pertaining to manufacturing and design techniques. (4) explanation of the degree to which the information concerns a service that is subject to competition: The information for which confidentiality is sought is employed in the design and manufacture of medical implant devices that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. (5) explanation of how disclosure of the information could result in substantial competitive harm: Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. (6) identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. (7) identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought.. (8) justification of the period during which the submitting party asserts that material should not be available for public disclosure: This material should not be disclosed for at least ten years. While improvements in design are likely to be made during this period, disclosure of the design information would lead to insights into both designs and manufacturing techniques and could have an adverse competitive effect for many years to come. This application contains information that will be used in future applications for similar devices. Moreover, the communications aspects of this device are employed in the programming of a medical implant device and in the transmission of highly private medical information to and from the device. Disclosure of the information for which Equipment Authorization Branch September 9, 2013 Page 3 confidentiality is sought could jeopardize the protection of such personal private medical information generated for the benefit of patients into whom the device has been implanted. As such, it is important that information pertaining to the design and operation of this device not be made available to unauthorized persons who might attempt to use knowledge of the design to compromise the applications for which the equipment will be employed. (9) any other information that the party seeking confidential treatment believes may be useful in assessing whether its request for confidentiality should be granted: See item 8 above. Note that the equipment for which approval is being sought will be employed in applications that inherently carry a premium on security.
FCC Home | Search | RSS | Updates | E-Filing | Initiatives | Consumers | Find People Office of Engineering and Technology Subject: Response to Inquiry to FCC (Tracking Number 885182) (TCB) From: <[email protected]> Date: 9/30/2013 8:34 AM To: <[email protected]> Link to Federal Communications Commission Home Office of Engineering and Technology Inquiry on 08/22/2013 : Inquiry: An applicant, Medtronic Inc, has requested long term confidential treatment of their internal photos. I've attached their request for confidentiality letter. They are seeking authorization under FCC 95I. Medtronic has a history of obtaining long term confidential treatment of their internal photos. Reference: FCC ID: LF5MICSW2. Based upon this prior history, and the justification they've provided in the attached letter, we are seeking the Commission's permission to upload the internal photos as long-term confidential exhibits. We understand this would be a waiver to the policy stated in FCC KDB 726920 D02 v02, Item c. Thanks. FCC response on 08/27/2013 Internal photos of a non-consumer device may be held confidential if the device is not accessible to the general public (for example a device mounted on the top of a large tower (or in a fenced enclosure) that is only serviceable by the licensee or designated technicians); The confidentiality request is acceptable by the FCC. FCC Publication # 726920 D02 V02 Item C dated 12/3/2012 requires additional information which is the NDA )Non Disclosure Agreement). See below: When confidentiality of Internal Photos or Users Manuals is requested, you must submit the following: A Cover Letter exhibit signed by the applicant or the applicant’s agent that describes the non-routine confidentiality request and the specific justification for the request. Your company has submitted Response to Inquiry to FCC (Tracking Number 885182) (TCB) 1 of 29/30/2013 9:45 AM In examples b) and c) above (internal photos of a non-consumer device and users manuals), you must include as a Cover Letter exhibit a signed copy of a non-disclosure agreement (NDA) between the grantee and the purchaser that lists the confidential item and describes the reason confidentiality is requested. Your company has NOT submitted.. Provide the NDA. ---Reply from Customer on 09/23/2013--- In response to the FCC's request, the applicant (Medtronic Inc.) has provided the attached updated Request for Confidentiality letter. This supersedes the letter that was uploaded as part of the original inquiry on 8/22/13. FCC response on 09/30/2013 The revised/updated confidentiality submitted to the FCC 9/23/2013 is acceptable. You may proceed with your application processing. Attachment Details: Updated Request for confidentiality Request for confidentiality letter Do not reply to this message. Please select the Reply to an Inquiry Response link from the OET Inquiry System to add any additional information pertaining to this inquiry. Response to Inquiry to FCC (Tracking Number 885182) (TCB) 2 of 29/30/2013 9:45 AM
Medtronic Reveal LINQ LNQ11 Insertable Cardiac Monitor External Photographs 1. Reveal LINQ Front 2. Reveal LINQ Back 3. Reveal LINQ Left Side 4. Reveal LINQ Right Side
A70429 REV A Sheet 1 of 1 LNQ11 9538 WWWDEV000W WWWPAO000W 2000-00-00 YYYY-MM-DD PIN: 0000W0000W LNQ11 Reveal LINQ LNQ11 / Reveal 9538 TM ® (01)00000000000000(17)000000(21)WWWDEV000W (01)00000000000000(17)000000(21)WWWDEV000W End label 1 Serial number Use by Serial number (01)00000000000000(17)000000(21)WWWDEV000W (01)00000000000000(17)000000(21)WWWDEV000W End label 2 Reveal LINQ LNQ11 / Reveal 9538 TM ® LNQ11 9538 WWWDEV000W WWWPAO000W 2000-00-00 YYYY-MM-DD PIN: 0000W0000W LNQ11 Serial number Use by Serial number Implantation date: LNQ11 Reveal LINQ LNQ11 TM WWWDEV000W WWWDEV000W 2000-00-00 YYYY-MM-DD 2000-00-00 YYYY-MM-DD Implantation date: Reveal LINQ LNQ11 TM 2000-00-00 YYYY-MM-DD FYR (For your records) labels Serial number Use by Reorder number Use by Serial number Use by WWWDEV000W 2000-00-00 YYYY-MM-DD Implantation date: Reveal LINQ LNQ11 TM Serial number Use by Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM Medtronic LNQ11 Reveal LINQ TM WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number WWWDEV000W Serial number Reveal LINQ LNQ11 / Reveal 9538 TM ® Medtronic, Inc. Minneapolis, MN 55432-5604 USA Manufactured in: Tolochenaz, Switzerland Product of Switzerland www.medtronic.com Insertable Cardiac Monitor system Single sterile barrier MR conditional LNQ11 Recording OFF Package contents: Insertable Cardiac Monitor Insertion tool Incision tool Insertion tool plunger Patient Assistant model 9538 Product documentation 2000-00-00 YYYY-MM-DD LNQ11 9538 LNQ11 WWWDEV000W WWWPAO000W Humidity limitation Type BF applied part FCC ID: LF5MEDSIMPLANT1 Implantable device (coated) Shelf box label Battery (2x)Patient Assistant case Transit temperature -18°C / 55°C 0°F / 131°F Storage temperature 5°C / 40°C 41°F / 104°F CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Serial number Serial number Reorder number Use by Consult instructions for use Sterilized using ethylene oxide Recording OFF Package contents: Insertable Cardiac Monitor Insertion tool Incision tool Insertion tool plunger Insertable Cardiac Monitor Medtronic, Inc. Minneapolis, MN 55432-5604 USA Manufactured in: Tolochenaz, Switzerland www.medtronic.com Single sterile barrier MR conditional FCC ID: LF5MEDSIMPLANT1 Implantable device (coated) Sterile pack label Reveal LINQ LNQ11 TM Storage temperature 5°C / 40°C 41°F / 104°F Consult instructions for use 2000-00-00 YYYY-MM-DD Use by WWWDEV000W Serial number Do not reuse CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Sterilized using ethylene oxide Do not use if package is damaged
Medtronic Confidential Medtronic Reveal LINQ LNQ11 Antenna Information Inductive Telemetry MedRadio Telemetry Max Gain (dBi) N/A -26.5 dBi (as measured in 4 g/l saline) Type Wire Coil, integrated Serpentine monopole, integrated Manufacturer Medtronic Medtronic Part Number M948524A003 M950940A002 Loss of Antenna Cable (dB) N/A N/A 1. Reveal LINQ Inductive Telemetry Antenna MedRadio Wing Band Transmitter Telemetry-B Inductive Telemetry Antenna Me An 2. Revea ‐Matt Kir k ‐Yogi Shah 13 August edRadio tenna al LINQ Med kwood h t 2013 Radio Anten Medtro nna onic Confidenntial
16 Augus To who m The Med t operates i tune‐up p that it doe transmitte that it doe parameter Respectf u Matthew Principal Medtroni c t 2013 it may conc e tronic Reveal in the MedRa process. The tr es not exceed er is adjusted es not exceed rs are configu ully, Kirkwood Systems Eng i c, Inc. ern: LINQ™ LN Q dio band betw ransmitter po the value sho during produ the occupied urable by the ineer Q11 Insertable ween 401.36 a ower output is own on the FC uction test an d bandwidth r user. e Cardiac Mon and 401.64 MH s fixed and is CC grant of ce nd the occupie requirements nitor contain Hz. This tran s verified duri ertification. T ed bandwidth for the MedR s a radio tran nsmitter has n ing productio The frequency h is then verif Radio wing ba Me 82 M o ww nsmitter that no provisions on test to conf y deviation of fied to confirm ands. No rad edtronic, Inc 00 Coral Se a ounds View, M ww.medtronic for a firm f the m io . a St. SE MN 55118 c.com
In FCC KDB 447498 General RF Exposure Guidance D01 v05r01, Section 4.2.4, the FCC provides a power threshold, below which implanted devices are excluded from SAR measurement or numerical simulation: "Transmitters implanted in the body of a user When the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is ≤ 1.0 mW, SAR test exclusion may be applied. The maximum available output power requirement and worst case operating conditions must be supported by power measurement results and fully justified in a SAR analysis report, in lieu of the SAR measurement or numerical simulation, according to design and implementation requirements of the device." Since both the radiated output power and conducted output power are well below 1.0 mW, this device is excluded from SAR measurement or numerical simulation. FCC ID: LF5MEDSIMPLANT1 is compliant with FCC RF Exposure requirements.
Medtronic Inc. Reveal LINQ™ FCC 95I:2013 Report #: MDTR0228.1 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: June 11, 2013 Medtronic Inc. Model: Reveal LINQ Emissions Test Description Specification Test Method Pass/Fail Radiated Power (EIRP) FCC 95I:2013, FCC 2.1046:2013 ANSI/TIA/EIA-603-C:2004 Pass Spurious Radiated Emissions FCC 95I:2013, FCC 2.1053:2013 ANSI/TIA/EIA-603-C:2004 Pass Emission Bandwidth FCC 95I:2013, FCC 2.1049:2013 ANSI/TIA/EIA-603-C:2004 Pass Emission Mask FCC 95I:2013, FCC 2.1049:2013 ANSI/TIA/EIA-603-C:2004 Pass Frequency Stability FCC 95I:2013, FCC 2.1055:2013 ANSI/TIA/EIA-603-C:2004 Pass Deviations From Test Standards None Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 9349 W Broadway Ave. Brooklyn Park, MN 55445 Phone: (763) 425-2281 Fax: (763) 424-3469 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834E-1). This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2013.03.8 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is listed below. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 3.80 -3.80 AC Powerline Conducted Emissions (dB) 2.94 -2.94 REV 2013.02.26 LOCATIONS Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 NVLAP NVLAP Lab Code: 200630-0 NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200629-0 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Informatio…
Text truncated - open the document above for the full version.
Emissions Mask XMit 2013.02.28 NORTHWEST Emissions Mask PsaTx 2013.06.07 EMC DIRECT 002.jpg DIRECT 003.jpg Emissions Mask Report No.MDTR0228.11/7 photo FF SE 004.jpg FF SE 001.jpg Field Strength of Fundamental PSA-ESCI 2012.12.14 Report No.MDTR0228.12/7 photo FF SE 002.jpg FF SE 003.jpg Field Strength of Fundamental PSA-ESCI 2012.12.14 Report No.MDTR0228.13/7 Frequency Stability XMit 2013.02.28 NORTHWEST Frequency Stability PsaTx 2013.06.07 EMC TEMP CHAMBER 001.jpg TEMP CHAMBER 002.jpg Frequency Stability Report No.MDTR0228.14/7 Emission Bandwidth XMit 2013.02.28 NORTHWEST Emission Bandwidth PsaTx 2013.06.07 EMC DIRECT 002.jpg DIRECT 003.jpg Emission Bandwidth Report No.MDTR0228.15/7 photo FF SE 001.jpg FF SE 002.jpg Spurious Radiated Emissions PSA-ESCI 2012.12.14 Report No.MDTR0228.16/7 photo FF SE 003.jpg FF SE 004.jpg Spurious Radiated Emissions PSA-ESCI 2012.12.14 Report No.MDTR0228.17/7
| # | Rule Parts | Frequency Range | Power Output | Emission | Tolerance |
|---|---|---|---|---|---|
| 1 | 95I | 401.36 MHz - 401.64 MHz | 0.10 µW | 46K9F1D | 76.7000000000 ppm |
Confirma DR/SR MRI SureScan, Effectra DR/SR MRI SureScan, Refina CSP DR/SR MRI SureScan, Restoria CSP DR/SR MRI SureScan, ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan
Equipment Class
DTS - Digital Transmission System
MyCareLink Home Communicator Model 26950
Equipment Class
DTS - Digital Transmission System
MyCareLink Home Communicator Model 26900
Equipment Class
DTS - Digital Transmission System
Implantable Neurostimulator
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
MCS3101CO
Equipment Class
DTS - Digital Transmission System